clinical trial · NCT05232825
A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis
Hoffmann-La Roche·phase3·completed·n = 236
Relapsing Multiple SclerosisPrimary Progressive Multiple SclerosisOcrelizumab IVOcrelizumab SCMethylprednisolone IVDiphenhydramine IVDexamethasone given orallyDesloratadine given orally
brief summary
This study will evaluate the pharmacokinetics, pharmacodynamics, safety, immunogenicity, and radiological and clinical effects of subcutaneous (SC) administration of ocrelizumab compared with the intravenous (IV) infusion of ocrelizumab in patients with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS).
started
May 3, 2022
primary completion
Mar 10, 2023
completion
Jun 6, 2025
last updated
Aug 6, 2025
official title
A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol